Kornimate/medical-research-clean huggingface dataset:
assessment of biomarkers in children to help parents quit tobacco

Conditions: Tobacco Dependence

Summary: this randomized controlled trial will test whether adding biomarker measurement and informed outreach for tobacco smoke exposure as part of routine practice increases identification and improves treatment, effectiveness, and sustainability of a parental tobacco control intervention that will be integrated into pediatric practice.

this trial will examine the effectiveness of systematic cotinine testing of children 12 years old or younger using blood already collected at any visit to a practice that sees pediatric patients where there is a clinically indicated blood draw. we hypothesize that providing cotinine biomarker results to pediatricians, personalized cotinine feedback to parents about their child's toxin exposure, and offering support to all household tobacco users to quit tobacco use (biomarker informed outreach (bio)) when added to the clinical effort against secondhand smoke exposure (cease) intervention will increase delivery of tobacco cessation assistance, increase household cessation, reduce tobacco smoke exposure in children, and be cost-effective. this is a 2-arm randomized controlled trial with family-level randomization to either cease+bio or cease arms at the time of the child's baseline visit. to compare the effectiveness of cease+bio vs. cease, we will follow-up with enrolled parents 12 months later to assess parental quit rate and children's tobacco smoke exposure.

Eligibility criteria:
inclusion criteria: 1. child 12 years old or younger presenting for a visit. 2. child scheduled for or has had a clinically indicated blood draw at that visit 3. parent/legal guardian of the child. 4. parent/legal guardian is a current smoker (past 7 days). exclusion criteria: 1. parent/legal guardian is non-english speaking. 2. parent/legal guardian is less than 18 years of age.

Keywords: tobacco control tobacco treatment pediatrics parents
safety, pharmacokinetics, and preliminary efficacy of isatuximab in patients awaiting kidney transplantation

Conditions: Immune System Disorder

Summary: primary objectives: * phase 1: to characterize the safety and tolerability of isatuximab in kidney transplant candidates. * phase 2: to evaluate the efficacy of isatuximab in desensitization of participants awaiting kidney transplantation. secondary objectives: * phase 2: to characterize the safety profile of isatuximab in kidney transplant candidates. * to characterize the pharmacokinetic (pk) profile of isatuximab in kidney transplant candidates. * to evaluate the immunogenicity of isatuximab. * to assess the overall efficacy of isatuximab in desensitization of participants awaiting kidney transplantation.

the study had a screening period of up to 28 days, a treatment period of up to 12 weeks, a site visit fup of up to 26 weeks, and an extended follow-up (fup) until study cut-off. the study duration involved site visit per participant (i.e., screening, treatment, site visit fup was approximately 42 weeks. the study duration included extended fup per participant was approximately 97.7 weeks (depending on when the participant was enrolled).

Eligibility criteria:
inclusion criteria: * diagnosis of chronic kidney disease (ckd) and active candidate on the kidney donor waitlist at the time of screening. * body mass index (bmi) \</=40 kg/m\^2. * contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * capable of giving signed informed consent. for participants in cohort a: active candidates on the kidney waitlist with living donor. for participants in cohort b: active candidates on the kidney waitlist with no living donor cleared for donation. exclusion criteria: * significant cardiac dysfunction. * known active, recurrent, or chronic infection. * active lupus or uncontrolled diabetes. * prior treatment with rituximab within 6 months from sar650984 administration. * inadequate organ and bone marrow function at screening. * pregnant or breastfeeding women or women who intend to become pregnant during participation in the study. * known intolerance or hypersensitivity to any component of sar650984 or pre-medications. * participants who were not suitable for participation as judged by the investigator. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Keywords: anti-cd38 monoclonal antibody
psychological aspects and patients compliance to restricted-protein regimens in chronic kidney disease

Conditions: Psychological Characteristics Involved in Dietary Compliance

Summary: dietary management of ckd patients proved important to postpone dialysis. long-term compliance to protein-restricted diets was discussed. psychological aspects involved in certain dietary behaviour have never been studied.

the interest in dietary management resurged, since the high prevalence of revealed a major impact not only on morbidity, mortality, social activities and patients' quality of life, but also on health budget. although protein-restricted diets are used for more than a century in patients with advanced chronic kidney disease (ckd), their efficacy and safety is still debatable. enough evidence has being accumulated on their role in postponing dialysis initiation in compliant patients. consequently, the long-term compliance to the diet is discussed. psychological aspects of compliant patients are certainly involved. identification of certain psychological predictors of dietary compliance could help to select the patients who are more likely to be compliant and therefore to benefit from such an intervention. moreover, short-term or long-term psychological intervention addressing these factors could increase patient long-term compliance. accordingly, we are aiming to evaluate psychological characteristics of chronic kidney disease patients in relation with their compliance to protein-restricted regimens.

Eligibility criteria:
inclusion criteria: * adult patients * stage 4+ ckd * good nutritional status (subjective global assessment score a/b and serum albumin ≥3.5 g/dl) * declared potentially good compliance with a low protein diet and agreed to follow the monitoring schedule are considered for the program exclusion criteria: * poorly controlled arterial blood pressure (≥145/85 mm hg) * uncontrolled diabetes mellitus * other relevant comorbidities (heart failure, active hepatic disease, digestive diseases with malabsorption, inflammation/anti-inflammatory therapy) * uremic complications (pericarditis, polyneuropathy) * feeding inability (anorexia, nausea)

Keywords: ckd patients protein-restricted diets compliance psychological aspects
effectiveness of pain neuroscience education (pne) to veterans with post-traumatic stress and low back pain

Conditions: Chronic Low Back Pain; Post-traumatic Stress

Summary: this trial compared traditional pain and stress education plus physical therapy to pain neuroscience education plus physical therapy in individuals with post-traumatic stress and chronic low back pain.

veterans and service members with low back pain (lbp) will be recruited for this research. once veterans consent to participate in this research, participants will undergo baseline testing. next, participants will randomly be assigned to one of two types of education: pain neuroscience education or traditional biomedical education. each veteran will receive 30 minutes of interactive education once a week for 4 weeks, depending on their group assignment. following each education session, veterans will participate in an exercise class that will last approximately 30 minutes. after the 4 week intervention, veterans will complete the same questionnaires and measures as at the beginning of the program. veterans will also complete subjective questionnaires at 8 weeks. finally, healthcare utilization will be measured for 12 months following the research intervention.

Eligibility criteria:
inclusion criteria: * pain located between the 12th rib and buttocks that in the opinion of the screening examiner is originating from the lumbar region * current episode of back pain duration of 3 months or longer * active duty military or veteran * read and speak english well enough to provide informed consent and follow study instructions exclusion criteria: * history of prior surgery to the lumbosacral spine within the previous 12 months * presence of neurogenic lbp defined by a positive contralateral straight leg raise (reproduction of symptoms below 45 degrees) or reflex, sensation, or strength deficits in a pattern consistent with nerve root compression * medical "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, infection, or systemic disease * discharged from physical therapy within the past 3 months for lower back pain * current diagnosis of psychotic conditions or medications (bi-polar, schizophrenia, personality disorder). * substance abuse or psychosis within 6 months of research. * unable to discontinue other active therapies until completion of clinical trial follow-up (8 weeks). * suicidal ideation * current pregnancy

Keywords: chronic low back pain post-traumatic stress physical therapy pain neuroscience education
study on plasmablastic lymphoma patients

Conditions: Plasmablastic Lymphoma

Summary: this is an observational, multicenter, international and retrospective study, that aims to collect data on clinical and pathological characteristics, treatment regimens, outcome, and prognostic factors (clinical, biomarkers and/or radio-metabolic) in patients affected by pbl.

this study is an international, multicenter, observational, retrospective trial on patients affected by pbl. the information collected aim to obtain data from the real-life diagnosis, staging, management and treatment and outcome of pbl patients. a centralized pathological review of pathological samples is planned to define the rate of accurate diagnosis and to define a recommended immunohistochemical diagnostic panel for pbl. in addition, exploratory analysis will be performed to better characterize pbl.

Eligibility criteria:
inclusion criteria: * diagnosis of plasmablastic lymphoma (pbl) between jan 1st 2000, and dec 31st 2022 * histologically confirmed plasmablastic lymphoma (pbl) diagnosis according to local pathological report * age \> 18 years old * availability of complete medical records * availability of histopathological material requested by the study exclusion criteria: * any other histology than pbl * lack of complete medical records * lack of histopathological material requested by the study

Keywords: plasmablastic lymphoma pbl
observed actions in chronic neck pain

Conditions: Chronic Pain

Summary: the aim of the present protocol is to prove if the observed actions (aob) will improve the cervical range of motion (crom) in patients with non-specific chronic neck pain (cnp). this study is a parallel-group double blind randomized clinical. outcome measures were crom, and pressure pain detection thresholds (ppdt) with a digital algometer. the follow-up will consist of three evaluations: pre- treatment, post-treatment and 10 minutes after second measurement (motor imagery).


Eligibility criteria:
inclusion criteria: * non specific chronic neck pain * diagnosed by medical specialist exclusion criteria: * cervical osteoarthritis or polyarthrosis * rheumatic disease * history of cervical hernia * whiplash syndrome * surgery on the neck, face or shoulders, * systemic disease, medical history of cancer * significant trauma that the patient relates to their pain and/or refusal to participate

Keywords: observed action range of motion mirror neuron
cyanoacrylate closure versus surgical stripping for incompetent saphenous veins

Conditions: Occlusions Vein; Chronic Venous Insufficiency

Summary: the purpose of this study is to evaluate the non-inferior, clinical outcomes after cyanoacrylate closure comparing the surgical stripping for incompetent saphenous veins.

varicose veins are highly prevalent. in western countries, an estimated 23% of adults have varicose veins, and 6% have more advanced chronic venous disease, including skin changes and healed or active venous ulcers. there are several modalities to treat varicose veins. open surgical treatment with ligation and stripping of the saphenous vein, combined with excision of large varicosities, has been the standard of care for many years. endovenous thermal ablation by radiofrequency ablation (rfa) or endovenous laser ablation (evla) has been shown to be a safe and effective alternatives with high long-term target vein closure rates. although both techniques have gained broad acceptance in many countries, one major disadvantage of these techniques is the requirement for use of tumescent anesthesia to avoid the thermal injury of the surrounding structures. cyanoacrylate closure for varicose veins has recently been introduced for treatment of the incompetent saphenous vein.

Eligibility criteria:
inclusion criteria: * age between 18 and 80 years of age at the time of enrollment * reflux in great saphenous vein greater than 0.5 seconds after distal compression and release or valsalva's maneuver in the standing or reverse trendelenburg position * diameter of saphenous vein between 2mm to 20mm (with standing position) * one or more of the following symptoms related to the incompetent saphenous vein: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling * clinical, etiologic, anatomic, and pathophysiologic classification of c2 through c5 exclusion criteria: * previous treatment in targeted vein segment * tortuous vein in which the delivery catheter cannot be inserted * aneurysm of target vein segment \>20 mm * daily use of narcotic or nonsteroidal anti-inflammatory pain medications to control pain associated with greater saphenous vein reflux * known hypercoagulable disorder * active malignancy * regular use of systemic anticoagulation * current use of systemic anticoagulant * previous deep vein thrombosis/pulmonary embolism or active acute superficial thrombophlebitis * unable to comply with the schedule and protocol evaluations * unable to ambulate * currently pregnant or breast feeding * known sensitivity to cyanoacrylate adhesives * symptomatic peripheral arterial disease with ankle-brachial index \<0.9 * participation in another clinical study that has not reached primary endpoint within 30 days prior to enrollment * any condition which in the opinion of the investigator could compromise subject safety or adherence to the protocol

Keywords: varicose vein stripping endovenous ablation occlusion quality of life
a safety and efficacy study of amdoxovir in hiv-1 treatment-experienced subjects.

Conditions: Human Immunodeficiency Virus Infection

Summary: this is a double-blind phase 2a study to test the safety and efficacy of an investigational hiv drug, amdoxovir (300 mg or 500 mg twice daily) compared with tenofovir df 300 mg once daily in hiv-1 infected antiretroviral therapy-experienced subjects who are currently failing antiretroviral therapy. there are three treatment groups (n=45). subjects will be randomized to receive either amdoxovir 300 mg twice daily (n=15) or amdoxovir 500 mg twice daily (n=15) or tenofovir df 300 mg once daily (n=15); each in combination with zidovudine 300 mg twice daily. the study will assess initially amdoxovir (300 mg or 500 mg twice daily) or tenofovir df 300 mg once daily, both in combination zidovudine 300 mg twice daily plus failing third drug, but then with lopinavir/ritonavir (400 mg/100 mg twice daily) after week 2. subjects who received amdoxovir (300 mg or 500 mg twice daily) and benefited from the drug may choose to enroll in the 36-week open-label study.


Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years old with hiv-1 rna ≥ 2,000 copies/ml and currently failing therapy. * has m184i/v mutation in addition to 0-2 thymidine analog mutations (tams) at screening. * agree to be abstinent or use two reliable forms of contraception (for females) and one form for men when participating in sexual activity that could result in pregnancy. exclusion criteria: * current or recent (last 30 days of study entry) aids defining diseases. * genotypic resistance testing at screening indicating k65r, l74v, q151m mutation. * prior exposure to lopinavir/ritonavir or amdoxovir. * impaired hepatic function (alt \> 5 x uln). * women who are pregnant or breast feeding.

Keywords: amdoxovir zidovudine tenofovir df hiv haart antiretroviral
efficacy of 0.28% sodium hyaluronate eye drops in patient with moderate to severe dry eye

Conditions: Dry Eye Disease (DED); Tear Break-Up Time; Tear Disorder; Tear Film Insufficiency; Tear Film Hyperosmolarity; Dry Eye; Hyaluronate; Hyaluronic Acid; Corneal Staining; Quality of Life

Summary: this study aimed to evaluate the efficacy and safety of 0.28% preservative-free sh and 0.18% sh eye drops in patients with dry eye disease. subjects diagnosed with dry eye disease and meeting the inclusion criteria (ocular surface disease index (osdi) score ≥ 23, fluorescein tear breakup time (tbut) \< 7 seconds were randomized into two groups. group 1 (42 eyes) received 0.28% sh, and group 2 (42 eyes) received 0.18% sh, both administered by a nurse. measurements included tear osmolarity (tearlab) before instillation and at 0,30 and 60 minutes post-instillation, recorded by a tearlab specialist. ophthalmologists assessed tbut, ocular surface staining (oxford grading scale), and the schirmer i test before instillation and evaluated adverse reactions up to 60 minutes post-instillation. subjects continued treatment for 30 days and were reevaluated during a second visit for osdi scores, tbut, the oxford grading scale, and adverse events. quality of life score were assessed at before and after treatment for 1 month.


Eligibility criteria:
inclusion criteria: * age more than or equal 18 year-old * ocular surface disease index (osdi) more than or equal 23 * oxford grading scale more than or equal 2 (both eye) * fluorescein tear break-up time less than 7 seconds (both eyes) * willing to being a subject in research. exclusion criteria: * diagnosed with other eye diseases that require medication which is not used to treat dry eye, such as glaucoma * history of ocular surgery in previous 3 months or refractive surgery in previous 6 months * history of ocular trauma, infection, ocular inflammation which is not involved with dry eye in previous 3 months * wear contact lenses * allergic to sodium hyaluronate * pregnant or lactation period * diagnosed with physical diseases that affect the eyes and cannot yet be controlled, such as uncontrolled dm (diabetes mellitus), active autoimmune disease, and systemic neuropathy induced neurotrophic keratopathy. - continuous use of medications for diseases such as retinoic acid derivatives, antihistamines, cholinergic agents, and antipsychotic agents which can lead to chronic dry eye * incompleted data.

Keywords: tear osmolarity artificial tears oxford grading scale deqs-th
safety and efficacy study of fentanyl buccal tablet use in the emergency department for isolated extremity injury

Conditions: Pain

Summary: the primary purpose of this study is to evaluate fentanyl buccal tablet (fbt) for analgesia in comparison to standard analgesia, to determine if the fbt allows for faster achievement of "significant analgesia"

the subjects/patients will be asked if they would desire a low dose or high dose pain medication regimen. the low dose (low-fbt) group will receive fbt at a dose of 100 mcg, as well as an oral (pill) placebo preparation. the low dose (low-control) group will receive an "inactive comparator" (lansoprazole rapidly-dissolving buccal 15mg, " fbt placebo") and a dose of 5/325 percocet tablet (oxycodone/acetaminophen 5/325). the high dose (high-fbt) group will receive 200 mcg fbt plus 2 placebo tablets. the high dose (high-control) group will receive the "fbt placebo" and a dose of 2, 5/325 percocet tablets.

Eligibility criteria:
inclusion criteria: * pain sufficient to warrant medication stronger than acetaminophen (tylenol) or aspirin * only if emergency department provider approves * a negative pregnancy test is required for participation for women of childbearing age exclusion criteria: * if treating provider determines intravenous analgesia is required * allergy to acetaminophen or any opiate/opioid, or lansoprazole patients currently taking phenothiazines, cns depressants (including alcohol), or if they have taken an monoamine oxidase inhibitor (maoi) or selective serotonin reuptake inhibitor (ssri) in the past two weeks * if patient has already been administered an opioid analgesic for their current injury * patients on chronic opioids therapy or a history of opioid abuse * breastfeeding mothers * patients who plan to drive home after their emergency department visit * history of phenylketonuria (due to phenylalanine in the formulation of the lansoprazole solutab)

Keywords: fentanyl buccal tablet
safety & efficacy of bct197 in patients undergoing cardiac surgery

Conditions: Acute Kidney Injury

Summary: this study will assess the safety and efficacy of bct197 on acute kidney injury in patients undergoing cardiac surgery with cardiopulmonary bypass.


Eligibility criteria:
inclusion criteria: * patients scheduled for elective cardiac surgery with cpb. allowable procedures are cabg alone, aortic valve replacement or repair alone, mitral valve replacement or repair alone, cabg with aortic valve replacement or repair, and cabg with mitral valve replacement or repair. patients with repeat surgery for any of the procedures can be included. * patients must weigh at least 50 kg to participate in the study, and must have a body mass index (bmi) 18 kg/m2 * have an egfr ≥ 30 and ≤ 60 ml/min/1.73 m2 to participate in part a, or an egfr \> 60 ml/min/1.73 m2 to participate in part b. upon completion of part a, patients with egfr ≥ 30 ml/min/1.73 m2 may participate in part b, with dose administered as per the dosing table exclusion criteria: * left ventricular ejection fraction, in the last 6 months, ≥30% * active systemic infection or uncontrolled diabetes mellitus with a glucose ≥250 mg% at the screening assessment * pregnant or nursing (lactating) women, * female subjects must either: have been surgically sterilized or hysterectomized at least 6 months prior to study participation, or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to study participation. in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow- up hormone level assessment is she considered not of child bearing potential, surgical sterilization procedures or hysterectomy must be supported with clinical documentation made available to the sponsor and noted in the relevant medical history / current medical conditions section of the crf, or be postmenopausal. female subjects are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms). female subjects 60 years of age or younger must confirm menopause by the demonstration of a plasma fsh level in the postmenopausal range according to the lab normal range. documentation of a prior plasma fsh level is acceptable * history of drug or alcohol abuse within the 12 months prior to dosing, or evidence of drug abuse as indicated by the laboratory assays conducted during screening or baseline * new cancer diagnosis with planned chemotherapy and/or radiation therapy, or cancer requiring ongoing chemotherapy and/or radiation therapy at the time of screening other protocol-defined inclusion/exclusion criteria may apply

Keywords: acute kidney injury cardiopulmonary bypass cabg cardiac surgery